Catheter for the Transvascular Implantation of Prosthetic Heart Valves

ABSTRACT

The invention relates to a catheter for the transvascular implantation of prosthetic heart valves, in particular comprising self-expanding anchorage supports ( 10 ), which allow a minimally invasive implantation of prosthetic heart valves. The aim of the invention is to reduce the risk to the patient during the implantation. To achieve this, according to the invention a prosthetic heart valve comprising anchorage supports is temporarily housed in a folded form in a cartridge-type unit ( 4 ) during the implantation. The cartridge-type unit can be fixed on the proximal end of a guide system ( 1 ), which comprises a flexible region ( 9 ) that can be guided through the aorta. Actuating elements ( 2, 3 ) run through the interior of the hollow guide system, said elements permitting sections of the cartridge-type unit to be displaced radially about their longitudinal axis and/or laterally in a proximal direction, thus allowing individual sections of the anchorage support and the associated prosthetic heart valve to be sequentially released.

The invention relates to catheters for the transvascular implantation ofprosthetic heart valves with self-expanding anchoring systems, by meansof which prosthetic heart valves can be implanted with minimal invasion.

It is becoming more frequently necessary for an increasing number ofpatients to have prosthetic heart valves implanted, for which purposeboth artificial and biological implants are used for heart valveprostheses.

In the past, such operations have been conducted in such a way that itas necessary to use a heart-lung machine on the anaesthetised patient.This therefore makes it a cost-intensive surgical intervention, whichsubjects the respective patients to a high degree of psychological andphysical stress. The aim is to keep the lethality risk below 3%. As theage of the respective patients increases and impairment of therespective heart valves becomes more advanced, a situation is reached inwhich patients in need of actual treatment become inoperable. Sincesurgical valve replacement is not possible for these patients, theysuffer from a reduce quality of life and have a considerably reducedlife expectancy. Intervention would pose an extremely high risk.

These same issues also apply to operations whereby prosthetic heartvalves with anchoring systems are implanted by means of so-calledballoon catheters.

In a procedure of this type, incorrect positioning can occur, which canhave considerable consequences for the patient, possibly leading to thedeath of the respective patient.

In recent times, therefore, attempts have been made to implant heartvalve prostheses by means of intervention methods involving minimalinvasion, whereby such prostheses are fed together with an anchoringsupport via the aorta of a patient and through the aorta to the heart.On reaching the implantation site at the heart, self-expansion of suchanchoring supports with a heart valve prosthesis attached to them isinitiated, the intended result being a reliable anchoring and exactpositioning of the heart valve prosthesis. Such anchoring supports havetended to be made from shape memory alloys, such as “Nitinol” forexample, and the alloy is selected so that its transition temperature isaround 37° C., and self-expansion can be initiated on reaching thetransition temperature.

As a result of such expansion, the anchoring support opens up so that itis able to lie against the aorta wall, where it can be securely fixed bymeans of additional barb elements if necessary. The heart valveprosthesis is folded open simultaneously, so that it is able to assumeits function.

An anchoring support of this type incorporating a heart valve prosthesisis described in patent specification WO 2004/019825 A1, for example.

Support hoops are provided at the proximal end of such an anchoringsupport, which can be introduced into the pockets of a patient's heartvalve, thereby enabling the anchoring support to be very accuratelypositioned by means of these support hoops during a surgicalintervention. What are referred to as commissural hoops are provided onthis anchoring support in addition, which, together with the supporthoops, clamp parts of a patient's old heart valve once the anchoringsupport has unfolded so that the anchoring support can be reliablypositioned and secured as a result of this clamping effect.

The support and commissural hoops of this known anchoring support shouldtherefore be disposed and dimensioned so that they permit a sequentialself-expansion. This means that the anchoring support is accommodatedinside a cartridge for the implantation procedure. It is then fed bymeans of a catheter through the aorta as far as the diseased heart. Onreaching the implantation site, the cartridge is manipulated so that thesupport hoops are released to allow them to self-expand. The cartridgeis then moved and oriented together with the anchoring support so thatthe support hoops are introduced into the pockets of the heart valve ofthe respective patient. This enables exact positioning to be achieved.

The respective cartridge is then further manipulated, so that thecommissural hoops are also released and able to self-expand. As thishappens, the old heart valve is clamped between the support andcommissural hoops and the heart valve prosthesis is opened-up into itsunfolded functional position.

After implanting the anchoring support incorporating the heart valveprosthesis, the catheter can then be removed from the patient's bodytogether with the cartridge through the aorta.

Although the support hoops provided on the anchoring support can resultin significantly easier and better positioning of the heart valveprosthesis to be implanted in the manner described above, there is apossibility of incorrect implantation and the heart valve prosthesis maynot be capable of functioning or may be so to only an unsatisfactorydegree. In certain situations, it is then no longer possible to remove anon-functioning or unsatisfactorily functioning heart valve prosthesisand it poses an increased risk of mortality for the respective patientin some cases.

The bend in the aorta in the human body during introduction through theaorta poses another problem during such surgical interventions. As thecartridge and the respective catheter are moved during this procedure, achange of direction of approximately 18° with a relatively small radiusof about 50 mm has to be negotiated without causing damage to the vesselwall.

Accordingly, the objective of the invention is to reduce risk to thepatient during implantation of prosthetic heart valves.

This objective is achieved by the invention on the basis of a catheterincorporating the characterising features defined in claim 1.Advantageous embodiments and designs of the invention may be obtained onthe basis of the characterising features defined in the dependentclaims.

In a preferred embodiment, a catheter proposed by the invention may beused in conjunction with a heart valve prosthesis with a self-expandinganchoring support of the type known from patent specification WO2004/019825 and the disclosed contents are included herein by way ofreference.

This being the case, the anchoring support with the heart valveprosthesis attached to it can be temporarily accommodated inside acartridge unit in a collapsed state during the implantation.

A cartridge unit prepared in this manner can be releasably attached tothe proximal end of a guide system. The cartridge unit and guide systemare minimised in term of their external diameter to the degree that theycan be fed through an aorta of a patient to be operated on without anydifficulty, and to this end, the total free cross-section availableinside the aorta should not be completely filled.

The guide system used is sufficiently long in terms of its length forthe cartridge unit to be fed with the guide system by introducing itinto the groin of a patient, through the aorta as far as the patient'sheart.

A flexible, bendable region is provided on the guide system, by means ofwhich a bending radius and bending angle can be achieved that willfollow and make allowance for the bend in the patient's aorta.

Elements for operating the cartridge unit are fed by means of the guidesystem, which has a hollow interior. These operating elements enableparts of the cartridge unit to be manipulated and moved in a specificway. For example, a radial or also lateral movement of parts of thecartridge unit can be effected by means of the operating elements.Moving parts of the cartridge unit in this specific way enables parts ofthe anchoring support to be released in sequence so that implantationand anchoring can take place in the manner described in WO 2004/019825.

For example, support hoops of an anchoring support can be released by arotation or by a lateral movement in the proximal or distal direction ofa part of the cartridge unit, but other parts, such as the commissuralhoops for example, continue to be retained inside the cartridge unit inthe collapsed state, which can subsequently be released with a view toexpansion by moving another part of the cartridge unit accordingly or bycontinuing the movement of the same part of the cartridge unit whichpreviously still enabled the support hoops to be retained inside thecartridge unit in the collapsed state.

The heart valve prosthesis, which is attached to the anchoring supportby stitching for example, opens simultaneously as the respective hoopsof the anchoring support, to which the heart valve prosthesis isattached, expand.

In a preferred embodiment, in addition to the operating elements forparts of the cartridge unit, other operating elements are fed throughthe internally hollow guide system, which act on the bendable region inorder to influence its curvature in a specific manner.

Due in particular to traction forces triggered via the operatingelements, a specific curvature of the bendable region can be achievedduring the implantation on penetrating the bend of the aorta. Tensioncables or tension wires may be used as the operating elements, which arerun through the internally hollow guide system as far as the proximaledge of the bendable region, where they are secured on the guide system,in which case the attacking points of the force of two such operatingelements should be disposed diametrically opposite one another and inaddition should be disposed at 90° with respect to the bending axisabout which the bendable region is required to curve.

For example, the curvature of the bendable region can be influenced in aspecific way by applying a traction force via one of the operatingelements as the guide system is pushed through the bend in the aorta bymeans of the bendable region and pulled out of it once the implantationhas been completed.

The bendable region of a guide system may be provided in the form of alink chain, in which the individual links are connected to one anotherby individual joints. This being the case, the individual jointspositively engage in respective adjacent links. They are designed sothat a curvature of more than 180° can be maintained in the bendingregion, with a bending radius which guarantees that at least the radiusof the bend in the aorta can be achieved.

The individual joints on the individual links of a link chain shouldalso be disposed diametrically opposite one another in pairs on theindividual links and parallel with the rotation axis of the bendableregion.

The guide system used with a catheter proposed by the invention shouldadvantageously also be designed so that a liquid coolant or apharmaceutical preparation can be circulated through the internallyhollow guide system as far as the cartridge unit. With the aid of such aliquid coolant, for example a salt solution, the anchoring support canbe kept below the transition temperature of the shape memory alloy. Thisalso prevents body fluids from being able to penetrate the interior ofthe guide system and a liquid pressure should therefore be maintainedwhich lends a sufficiently high resistance to penetration by body fluidor other elements contained in body fluid.

Introducing liquid coolant in an appropriate manner can also preventgas, for example air, from getting into the aorta and the blood.

To this end, the entire guide system should be as liquid-proof aspossible. Accordingly, a flexible, bendable region provided in the formof a link chain in this instance may be sealed from the outside by meansof a plastic hose to render it liquid-proof.

The parts of the cartridge unit which can be moved in a specific way inorder to release hoops of the anchoring support are preferably providedin the form of sleeve-shaped elements, the internal and externaldiameters of which are adapted to one another so that they can engage inone another telescopically, and at least two of the sleeve-shapedelements have mutually adapted internal and external diameters such thata collapsed anchoring support with heart valve prosthesis can beaccommodated between them and retained in the collapsed state.

When introducing the catheter, the cartridge unit should be completelyclosed as far as possible and to facilitate introduction through theaorta should have a tip at its proximal end, which is in turn preferablymade from a flexible material, for example silicone.

When the cartridge unit reaches the respective patient's heart, theappropriate manipulation can then be performed, in other wordsparts/sleeve-shaped elements of the cartridge unit moved, so that thedifferent hoops of the anchoring support are sequentially released andthe heart valve prosthesis secured to them simultaneously opened up.

As this happens, however, the anchoring support is still securelyretained on the cartridge unit. To this end, anchoring elements areprovided on one sleeve-shaped element of the cartridge unit, disposed atthe distal end, for example at a point where eyes are provided on theanchoring support. In this position, these anchoring elements togetherwith the distal part of the anchoring support are also covered by asleeve-shaped element of the cartridge unit, so that the distal part ofthe anchoring element is still retained in the collapsed state.

In this position, it is possible to check the function of the heartvalve prosthesis, which has already unfolded. Once it is evident thatthe heart valve prosthesis is functioning, a further manipulation may beeffected by moving the sleeve element that was previously covering theanchoring element with the distal part of the anchoring supportaccordingly, which causes the distal part of the anchoring support to befully released as well so that it can then fully unfold.

If, on checking, it is found that the implanted heart valve prosthesisis not fulfilling its function or is so but not satisfactorily, it isadvantageously possible to move the anchoring support together with theheart valve prosthesis back into the cartridge unit by moving theparts/sleeve-shaped elements in the opposite direction accordingly andremoving all the parts, in other words the entire catheter, from thepatient's body again, thereby significantly reducing the risk of theoperation, after which a further attempt at implantation can be made onthe same patient.

In one advantageous embodiment of the catheter proposed by theinvention, a guide wire can also be run through the entire catheter.Such guide wires are already used for operations of this type and theyare fed through the patient's aorta to a point behind the heart beforeintroducing the catheter. The catheter can then be placed over thecartridge unit and guide system and into the guide wire and pushed inalong it into the aorta as far as the patient's heart.

In order to monitor the process of introducing the catheter and alsomanipulation of the bendable region, in particular at the bend of theaorta, it is of advantage to provide marker elements on the guide systemand/or the cartridge unit, made from a material which absorbsX-radiation, so that the respective position can be pinpointed on anX-ray image during the operation.

A screen filter may also be used with the catheter proposed by theinvention, by means of which particles can be prevented from penetratingthe respective patient's blood circulation system. Such a screen filtermay be attached to the guide system so that it completely surrounds itin the radial direction. In this respect, it should be elasticallybiased so that it lies against the vessel wall of the aorta, therebyguaranteeing a closure that is impermeable to particles.

Furthermore, the catheter proposed by the invention may additionally beprovided with a conventional balloon disposed in the interior of theguide system or cartridge unit and carried with it there oralternatively it can be fed through the interior of the guide system asfar as the anchoring support to be expanded. Using such a balloon, thevolume of which can be increased by means of a fluid at increasedpressure, will further assist expansion of the anchoring support.

The operating elements described above, which may be fed through theinterior of the guide system and provided in the form of traction andcompression means, may advantageously be manipulated from a manipulatingpart. The manipulating part may be designed as a handle, by means ofwhich the movement for introducing the catheter can then be effected bythe respective surgeon.

Other control elements are also provided on such a manipulating part, bymeans of which the respective movement of the operating elements can beinitiated. This being the case, it should be possible to effect thecorresponding movement in as measured a manner as possible, for examplewith appropriate translation ratios, and it should be possible torestrict the respective movement by end stops or catch positions atleast. This enables specific maximum distances or angles to bepreserved, for which allowance can be made in achieving the sequentialexpansion of the anchoring support or the specific way in which thecurvature of the bendable region is influenced. In this respect, itshould be possible to adjust the end stops or individual catches asfinely as possible.

All the parts of a catheter proposed by the invention but at least thosewhich come into direct contact with the respective patient and are alsointroduced into the aorta should be made from bio-compatible materialswhich are compatible with the respective organism. It should also bepossible to sterilise them, in which case it should be possible to useone of the standard sterilisation processes.

The invention will be explained in more detail on the basis of examples.

Of the drawings:

FIGS. 1 to 4 are schematic diagrams illustrating an example of acatheter proposed by the invention during different possible phases ofan implantation procedure;

FIG. 5 shows an example of a catheter with a manipulating part and

FIG. 6 is an exploded diagram illustrating the manipulating partillustrated in FIG. 5.

FIGS. 1 to 4 are intended to illustrate and provide a clearerunderstanding of an example of a catheter proposed by the invention. Theindividual diagrams illustrate different phases which take place duringimplantation of an anchoring support 10 incorporating a heart valveprosthesis.

The example of a catheter proposed by the invention illustrated in FIG.1 is shown with the cartridge unit 4, which is still completely closed,containing an anchoring support 10 incorporating a heart valveprosthesis in the non-expanded state and thus collapsed, so that it canbe fed by means of the internally hollow guide system 1 through anappropriate access into the aorta and through it to the respectiveimplantation site on the patient's heart.

Proximally disposed on the cartridge unit 4 is a flexible tip made fromsilicone, which facilitates the introduction procedure and reduces therisk of damage.

Part 5 of the cartridge unit is releasably connected to the other partsof the guide system 1, for example by means of a screw connection.

Adjoining the cartridge unit 4 is a bendable region 9, which is designedand dimensioned so that it is guaranteed to be able to move through thebend of a patient's aorta without causing problems.

Possible designs of such a bendable region 9 will be explained below.

Other parts of the internally hollow guide system 1 are also illustratedand FIGS. 1 to 4 show two operating elements 2 and 3 running through theguide system 1 as far as the cartridge unit 4, and in this instance theoperating element 2 likewise runs through the internally hollowoperating element 3 as far as the cartridge unit 4.

The operating elements 2 and 3 in this instance are provided in the formof lengths of compression spring, which are preferably reinforced bymeans of tension wire. Such tension wires make the catheter safer as itis being removed from the patient's body once the operation is complete.

Other parts 11 of the guide system 1 are illustrated on the left-handside, which may be provided in the form of more or fewer sleeve-shapedparts, although these must be secured so that they are sufficientlypressure- and tension-resistant to withstand introduction into the aortaand extraction from the aorta again. Appropriately stiff plastic hosesmay be used for this purpose, for example PTFE hoses or hoses with aPTFE base, because they are sufficiently compatible with the organismand can also be sterilised.

FIG. 2 illustrates the procedure which takes place during a first stageof the operation on reaching the implantation site on the respectivepatient's heart. The part/sleeve-shaped element 7 of the cartridge unit4 can be pulled back in the distal direction by a distal movement of oneof the operating elements 2 and/or 3 so that some hoops of the anchoringsupport 10, for example and preferably the support hoops provided on theknown heart valve prosthesis disclosed in WO 2004/019825 A1, expand andare biased radially outwards.

The entire catheter with the guide system 1 and the cartridge unit 4 cantherefore be pushed proximally and these hoops (support hoops)introduced into the pockets of the patient's old heart valve. When thesurgeon feels a perceptible resistance, the process of introducing thesupport hoops of the anchoring support 10 into the pockets of the oldheart valve is complete.

The part/sleeve-shaped element 5 of the cartridge unit 4 can then bemoved distally forwards, so that other hoops of the anchoring supportcan then also be released so that they can self-expand and open up theheart valve prosthesis.

A preliminary stage of this is illustrated in FIG. 3, where a heartvalve prosthesis has not yet been fully unfolded and the anchoringsupport 10 can also not yet be fully anchored.

As also illustrated in FIG. 3, a distal part of the anchoring support 10is still accommodated inside the cartridge unit 4, underneath thepart/sleeve-shaped element 7 in the cartridge unit 4. This remains thecase until the process of unfolding and positioning the heart valveprosthesis has reached the stage where its functionality can be checked.

If the check reveals incorrect functioning or faulty positioning, thepart/sleeve-shaped element 7 can be pushed proximally again by one ofthe two operating elements 2 or 3 so that the anchoring support 10 withthe heart valve prosthesis is at east partially accommodated in thecartridge unit 4 again and then the entire catheter can be removed fromthe patient by pulling it out of the aorta without causing damage to thevessel wall.

If the function test reveals that the heart valve prosthesis is able tofulfil its function to at least a sufficient capacity, thepart/sleeve-shaped element 7 may be moved distally back, as illustratedin FIG. 4, or another part/sleeve-shaped element 6 of the cartridge unit4 may be pushed in the proximal direction so that the distal part of theanchoring support 10 can also be released and expand fully.

As also illustrated in FIG. 4, eyes or other appropriate elements areprovided at distal end regions of the anchoring support 10, which werepreviously engaged in anchoring elements 8 provided on thepart/sleeve-shaped element 6. These eyes and the anchoring elements 8ensure reliable retraction or extraction if it is established that ananchoring support 10 incorporating a heart valve prosthesis has beenincorrectly or badly implanted, enabling the anchoring support 10 andheart valve prosthesis to be removed from the patient's body.

By means of the anchoring elements 8 as well as other guide elements 16which may optionally be provided on the part/sleeve-shaped element 6 ofthe cartridge unit 4, it is also possible to effect a radial turningmovement to enable the hoops of an anchoring support 10 to be introducedinto the pockets of an old heart valve prosthesis in an exactly correctangular position, for example, in which case the entire catheter can beturned slightly about its longitudinal axis by the surgeon during theimplantation.

Detail A of FIG. 4 also specifically illustrates a cannula 12, which isfed through the cartridge unit 4 along its longitudinal axis. By mans ofthe cannula 4, the guide wire described in the general part of thedescription can be fed through cartridge unit 4.

FIG. 5 illustrates an example of a catheter with an additionalmanipulating part 13, on which other control elements are provided inorder to permit manipulation.

The guide system 1 together with the cartridge unit 4 described abovewith reference to FIGS. 1 to 4 are also used in this example.

However, detail A illustrates one possible design of the bendable region9 in the form of a link chain.

The individual links 9.1 are generally of the same shape and dimension.

In this respect, the oppositely lying end faces of the individual links9.1 are shaped so as to form individual joints 9.2, each of whichpositively engages in adjacent individual links 9.1 and as a result ofgaps with a sufficient gap width between the individual links 9.1respectively ensure that the bendable region bends about at least 1800as mentioned above, with a radius of approximately 50 mm.

The individual joints 9.2 are formed by a cut-out in the respectiveoppositely lying end faces of the individual links 9.1, whereby aco-operating cut-out on one end face and a co-operating rounded,complementary protruding area on the diametrically opposite end face ofthe individual links 9.1 form the individual joints 9.2 on respectiveadjacent individual links 9.1.

Although not illustrated, the bendable region 9 may be enclosed by aplastic hose to render it fluid-tight.

FIG. 5 also illustrates how a manipulating part 13 may be provided toenable a catheter proposed by the invention to be introduced andmanipulated.

A handle 13.1 is provided for introducing and extracting the catheterwith the guide system 1 and cartridge unit 4.

A fluid-tight closure in the form of a plate 17 is provided in theproximal part of the manipulating part 13, enabling the guide system 1to be flange-mounted by means of a locking nut 23, and seal elements areprovided, although these are not illustrated here.

A standard Luer connection 30 is also provided, by means of which thecoolant liquid can be circulated.

The respective curvature of the bendable region 9 can be obtained usingthe handle 19, which can be turned about an axis by means of tensioncables (not illustrated) and this will be further explained with thedescription of FIG. 6.

The entire manipulating part 13 should be sealed with respect to thesurrounding environment and with respect to the guide system 1 so thatit is as far as possible fluid-tight and also gas-tight if necessary.

The tube 28 can be moved laterally in the proximal direction by means ofthe lever 20 acting on the handle 13.1, and the corresponding movementand resultant traction or compression force transmitted to one of thetwo operating elements 2 and/or 3, thereby enabling a manipulation ofthe individual parts/sleeve-shaped elements 5, 6 and/or 7 of thecartridge unit 4 in the manner described above, for example in finelymeasured doses via the pumping movements of the lever 20.

The pushing handle 25 enables the position of part 5 of the cartridgeunit 4 to be manipulated relative to the sleeve-shaped part 6 of thecartridge unit 4 in the extension beyond the length of spring by meansof the fixing hooks, serving as anchoring elements 8. The pushing handle25 is latched in a thread-shaped toothing 28.1 of a tube 28 by means ofa compression spring. As a result, the pushing handle 25 follows theproximal movement of the tube 28, which is connected to part 6 of thecartridge via the length of spring serving as an operating element 3.

On reaching an end stop marking the first discharge stage, the pushinghandle 25 can be turned in order to effect a finely measured axialdisplacement of part 5 of the cartridge unit 4 relative to part 6 of thecartridge unit 4 in the direction of the pitch of the thread 28.1.

With respect to operating the pushing handle 25, the latter is able tomove the part 5 of the cartridge unit 4 illustrated here without anadditional fine adjustment.

Such a manipulation enables the anchoring support 10 to be released (seeFIG. 3) and in this position, the anchoring support 10 can still beretracted.

When the stop 29 is released by means of an actuator member 31 providedin the form of an adjusting screw for example, the cartridge unit 4 maybe extracted farther by operating the lever system 20 in the mannerdescribed above until the retaining eyes of the anchoring support 10have moved away from the cartridge unit 4 and the anchoring support 10is able to spring away from the anchoring elements 8 due to itsexpansion forces.

The elements of the cartridge unit 4 may be pulled back in stages. Thisbeing the case, part 5 of the cartridge unit 4 may be retracted bypulling back the pushing handle 25 (pushing element latched) beyond part6 of the cartridge unit 4.

By operating a releasing bolt 32, part 6 of the cartridge unit 4connected to the tube 28 can also be returned to its initial position bypulling the pushing handle 25 farther back so that the cartridge unit 4is then completely closed again. In this state, the catheter can beremoved from the patient's body again.

FIG. 6 is an exploded diagram providing a more detailed illustration ofthe manipulating part 13 used in this example.

As illustrated, when the handwheel 19 is turned via the shaft 14, twotoothed racks 24 oriented parallel with one another can be displaced.Accordingly, one toothed rack 24 is moved in the proximal direction asthe toothed rack 24 oriented parallel with it is moved in the distaldirection.

Although these are not illustrated here, tension cables may be securedto clamping jaws 21 acting on the co-operating toothed racks 24, whichare fed through the internally hollow guide system 1 as far as thebendable region 9 and are preferably secured in its proximal region.

By turning the handwheel 19 accordingly, a traction force can be appliedto at least one of the two tension cables, causing the bendable region 9to assume the appropriate curvature in measured doses so that the guidesystem 1 can be fed through the bend of the aorta in a defined mannertogether with the cartridge unit 4.

As also illustrated in FIG. 6, the lever 20 connected to the handle 13.1acts via fine toothing 28.1 on the tube 28, enabling it to bemanipulated via the operating elements 2 and/or 3 to permit thesequential release of the anchoring support 10.

1. Catheter for the transvascular implantation of heart valve prosthesiswith a support element, comprising: a cartridge unit configured to holdthe support element in a collapsed state; and operating elementsdisposed within a hollow guide system and extending to the cartridgeunit, the operating elements configured to affect movement of thecartridge unit rotatably about its longitudinal axis to affect movementof the support element rotatably and axially along its longitudinal axisin at least one of the proximal and distal directions to affect asequential release of a hoop element of the support element forintroduction into a pocket of a heart valve followed by a release of aremainder of the support element to clamp at least a portion of theheart valve between the hoop element and the remainder of the supportelement.
 2. Catheter as claimed in claim 1, further including a bendableregion.
 3. Catheter as claimed in claim 2, wherein the bendable regionincludes a plurality of joints and is configured to affect a bend in thecatheter of 180 degrees. 4-5. (canceled)
 6. Catheter as claimed in claim1, wherein a liquid coolant is circulated through the interior of theguide system as far as the cartridge unit.
 7. Catheter as claimed inclaim 6, wherein the guide system is configured to be liquid-proof. 8.Catheter as claimed in claim 1, wherein the cartridge unit is providedwith first and second cartridge elements telescopically disposed withrespect to one another, and wherein the support element and heart valveprosthesis are held in the collapsed state by the first and secondcartridge elements.
 9. Catheter as claimed in claim 1, wherein thecartridge unit includes at least one cartridge element configured toselectively engage the support element via a plurality of anchoringelements mounted on the cartridge element. 10-16. (canceled) 17.Catheter as claimed in claim 8, wherein the first cartridge element ismovable in the distal direction to permit the hoop element toself-expand while the second cartridge element maintains the remainderof the support element in the collapsed state.
 18. Catheter as claimedin claim 17, wherein the second cartridge element is movable in theproximal direction to permit the remainder of the support element to atleast partially expand.
 19. Catheter as claimed in claim 9, wherein theplurality of anchoring elements are configured to permit rotation of thesupport element about a longitudinal axis of the catheter when thecartridge element is rotated.
 20. A catheter for implanting a heartvalve prosthesis connected to a support element including at least onesupport hoop, comprising: a first manipulating element; a secondmanipulating element configured to at least partially surround the firstmanipulating element; and a third manipulating element configured to atleast partially surround the second manipulating element; whereinrelative axial movement between the first, second, and thirdmanipulating elements is configured to permit sequential expansion ofthe support element from a collapsed form to an expanded form.
 21. Thecatheter of claim 20, wherein axial movement of the third manipulatingelement in a distal direction relative to the first manipulating elementis configured to permit the at least one support hoop to expand from acollapsed form to an expanded form.
 22. The catheter of claim 21,wherein axial movement of the second manipulating element in theproximal direction relative to the first manipulating element isconfigured to permit a remainder of the support element to expand from acollapsed form to a partially expanded form.
 23. The catheter of claim22, wherein axial movement of the third manipulating element in theproximal direction relative to the first manipulating element isconfigured to collapse the partially expanded remainder of the supportelement and collapse the expanded support hoop.
 24. The catheter ofclaim 22, wherein further axial movement of the third manipulatingelement in the distal direction relative to the first manipulatingelement is configured to permit the remainder of the support element toexpand from the partially expanded form to a fully expanded form. 25.The catheter of claim 22, wherein relative axial movement of the firstmanipulating element in the proximal direction relative to the thirdmanipulating element is configured to permit the remainder of thesupport element to expand from the partially expanded form to a fullyexpanded form.
 26. The catheter of claim 20, wherein: the firstmanipulating element includes anchoring elements configured toselectively engage the support element; and the first manipulatingelement and the support element are configured to rotate about alongitudinal axis.
 27. A catheter for implanting a support elementhaving at least one support hoop, comprising: a cartridge unit disposedbetween proximal and distal ends of the catheter configured to: affectexpansion of the at least one support hoop via movement of a firstelement in the distal direction, the expanded at least one support hoopconfigured to be introduced into a pocket of a native heart valve;affect expansion of a first portion of the remainder of the supportelement via movement of a second element in the proximal direction andmaintain a second portion of the remainder of the support element in acollapsed form via the first element; and affect contraction of theexpanded at least one support hoop and the expanded first portion of theremainder of the support element via movement of the first element inthe proximal direction.
 28. The catheter of claim 27, wherein thecartridge unit further includes a third element configured to affectrotation of the support element about a longitudinal axis of thecartridge unit.
 29. The catheter of claim 27, wherein the first elementis further configured to affect expansion of the second portion of theremainder of the support element via movement of the first element inthe distal direction.
 30. The catheter of claim 27, wherein thecartridge unit further includes a third element configured to affectexpansion of the second portion of the remainder of the support elementvia movement of the third element in the proximal direction.
 31. Thecatheter of claim 27, wherein: the cartridge unit is further configuredto affect expansion of the second portion of the remainder of thesupport element; and the expanded at least one hoop element and thefully expanded remainder of the support element are configured to clampat least a portion of the heart valve.
 32. The catheter of claim 27,wherein the at least one support hoop includes a plurality of supporthoops.
 33. A catheter for implanting a heart valve prosthesis attachedto a support structure having a body portion and at least one hoopelement, the catheter comprising: a first element configured toselectively maintain the at least one hoop element in a collapsed formby at least partially surrounding the hoop element; a second elementconfigured to selectively maintain the body portion in a collapsed formby at least partially surrounding the body portion; and a third elementconfigured to selectively engage the body portion; wherein axialmovement of the first element in a distal direction relative to thesecond element permits the at least one hoop element to self-expand, andaxial movement of the second element in a proximal direction relative tothe first element permits at least a portion of the body portion toself-expand.
 34. The catheter of claim 33, wherein the expanded at leastone hoop element is configured to be positioned in a pocket of a nativeheart valve.
 35. The catheter of claim 33, wherein: either axialmovement of the first element in a distal direction relative to thesecond element or axial movement of a third element in a proximaldirection relative to the first element permits the body portion tofully expand; and the expanded at least one hoop element and the fullyexpanded body portion are configured to clamp a native heart valvetherebetween.
 36. A catheter for implanting a support element supportinga valve prosthesis, comprising: a first element configured toselectively maintain a first portion of the support element in acollapsed form by at least partially surrounding the support element;and a second element configured to selectively maintain a second portionof the support element in a collapsed form by at least partiallysurrounding the support element; wherein the first element is configuredto selectively release the first portion to self-expand by movement ofthe first element in a first direction relative to the second element,and the second element is configured to selectively release the secondportion to self-expand by movement of the second element in a seconddirection relative to the first element, substantially opposite thefirst direction.
 37. A method of implanting a support element having avalve prosthesis connected thereto and including at least one supporthoop, comprising: positioning the support element in a collapsed formrelative to a native heart valve; expanding the at least one supporthoop from a collapsed form to an expanded form while maintaining theremainder of the support element in the collapsed form; positioning theat least one expanded support hoop into a pocket of the native heartvalve; partially expanding the remainder of the support element to atleast partially expand the valve prosthesis; and collapsing thepartially expanded remainder of the support element into the collapsedform.
 38. The method of claim 37, wherein the step of positioning the atleast one expanded support hoop includes rotating the support elementvia a catheter to position the support hoop in the pocket.
 39. A methodof implanting a support element having a valve prosthesis connectedthereto and including at least one support hoop, comprising: positioningthe support element in a collapsed form relative to a native heartvalve; expanding the at least one support hoop from a collapsed form toan expanded form while maintaining the remainder of the support elementin the collapsed form; positioning the at least one expanded supporthoop into a pocket of the native heart valve; partially expanding theremainder of the support element to at least partially expand the valveprosthesis; and checking the function of the valve prosthesis after thestep of partially expanding the remainder of the support element. 40.The method of claim 39, further including: determining that the valveprosthesis is functioning improperly; and collapsing the partiallyexpanded remainder of the support element into the collapsed.
 41. Themethod of claim 39, further including: determining that the valveprosthesis is functioning properly; and fully expanding the remainder ofthe support element.
 42. The method of claim 39, wherein the nativevalve is clamped between the at least one support hoop and the supportelement when the remainder of the support element is fully expanded. 43.A system for treating a heart valve, comprising: a support elementincluding a body portion configured to support a heart valve prosthesisand at least one hoop element connected to the body portion; and acatheter for positioning the support element relative to a native heartvalve configured to: expand the at least one hoop element and positionthe expanded at least one hoop element into a pocket of the native heartvalve, sequentially expand a first portion of the body portion andmaintain a second portion of the body portion in a collapsed form tocheck the functioning of the heart valve prosthesis, and sequentiallyexpand a second portion of the body portion to clamp at least a portionof the native heart valve between the at least one hoop element and thebody portion.
 44. A catheter for transvascular implantation of a heartvalve prosthesis with a self-expanding anchoring support, the cathetercomprising: (a) a cartridge unit for carrying the anchoring support andprosthesis and having a flexible tip at its proximal end; (b) a hollowguide system releasably connected to the cartridge unit at the proximalend of the hollow guide system; and (c) a manipulating part attached tothe distal end of the hollow guide system wherein operating elements areattached at one end to the manipulating part and at the other end to thecartridge unit, the hollow guide system has a bendable region at itsproximal end adjacent to the cartridge unit, the hollow guide system isconfigured to contain a circulating coolant or pharmaceuticalpreparation; and the guide system is substantially liquid proof. 45.Catheter as claimed in claim 44, wherein the bendable region includes alink chain with individual joints.
 46. Catheter as claimed in claim 45,wherein the individual joints positively engage respectively in adjacentlinks.
 47. Catheter as claimed claim 44, wherein the operating elementsinclude tension wires.
 48. Catheter as claimed in claim 44, wherein theguide system is configured to circulate the liquid coolant through aninterior of the guide system to the cartridge unit.
 49. Catheter asclaimed in claim 44, wherein the cartridge unit is provided with aplurality of sleeve-shaped elements telescopically engaging in oneanother, between which the anchoring support and heart valve prosthesisare enclosed and clamped in a collapsed state until implantation. 50.Catheter as claimed in claim 44, wherein a guide wire is fed through theinterior of the catheter.
 51. A replacement valve for use within a humanbody comprising: a valve component; a stent component comprising a firstsection, a second section for housing the valve component, and a thirdsection, wherein the third section comprises at least one attachmentelement configured for removable attachment to a delivery device. 52.The replacement valve of claim 51, wherein the at least one attachmentelement comprises a geometric opening configured for removableattachment to a complimentary element of the delivery device.
 53. Thereplacement valve of claim 51, wherein the at least one attachmentelement comprises a wire, hook, or strap configured for removableattachment to a complimentary element of the delivery device.
 54. Thereplacement valve of claim 51, wherein the at least one attachmentelement comprises at least two attachment elements.
 55. The replacementvalve of claim 51, wherein the at least one attachment element comprisesat least three attachment elements.
 56. The replacement valve of claim51, wherein the stent component comprises a lattice structurecomprising: at least one commissural post; and the at least oneattachment element.
 57. The replacement valve of claim 56, wherein thelattice structure further comprises at least one supporting element forconnecting the at least one commissural post to the at least oneattachment element.
 58. The replacement valve of claim 13, wherein thethird section has a diameter that is less than a diameter of the secondsection.
 59. A cardiac stent-valve delivery system comprising: a firstassembly comprising an outer sheath and a guide wire tubing; and asecond assembly comprising a stent holder configured for removableattachment to at least one attachment element of a stent-valve, thestent-valve positioned over the guide wire tubing of the first assembly,wherein the first assembly and the second assembly are configured forrelative movement with respect to one another in order to transitionfrom a closed position to an open position, such that in the closedposition the outer sheath encompasses the stent-valve still attached tothe stent holder and thus constrains expansion of the stent-valve, andsuch that in the open position the outer sheath does not constrainexpansion of the stent-valve and thus the stent-valve detaches from thestent holder and expands to a fully expanded configuration.
 60. Thestent-valve delivery system of claim 59, wherein the first assembly andthe second assembly are configured to transition from the closedposition, to a partially-open position, to the open position, wherein inthe partially-open position, the stent-valve expands partiallyproximally but does not detach from the stent holder because the outersheath still encompasses the at least one attachment element of thestent-valve and the stent holder.
 61. The stent-valve delivery system ofclaim 60, further comprising a flush mechanism.
 62. The stent-valvedelivery system of claim 59, further comprising at least one balloonconfigured to cause at least one of valvuloplasty prior to implantationof the stent-valve and expansion or post-dilation of the stent-valveupon inflation of the at least one balloon.
 63. The stent-valve deliverysystem of claim 62, wherein the at least one balloon is housed eitherproximally or distally to the stent-valve.
 64. The stent-valve deliverysystem of claim 62, wherein the at least one balloon is housed at leastpartially within the stent valve.
 65. The stent-valve delivery system ofclaim 59, further comprising a push handle for causing the relativemovement of the first assembly and the second assembly.
 66. Thestent-valve delivery system of claim 59, further comprising a screwmechanism for translating rotational movement of a handle into therelative movement of the first assembly and the second assembly.
 67. Thestent-valve delivery system of claim 59, further comprising anintegrated introducer within which the first assembly and the secondassembly are positioned during delivery of the stent-valve to animplantation site.
 68. The stent-valve delivery system of claim 59,wherein after expansion of the stent-valve to the fully expandedconfiguration, the delivery system is configured to return to the closedposition by passing the second assembly through the stent-valve towardsa distal end of the first assembly.
 69. The stent-valve delivery systemof claim 59, wherein the at least one attachment element of thestent-valve comprises a geometrical opening configured for removableattachment to a complimentary structure of the stent holder.
 70. Thestent-valve delivery system of claim 69, wherein the geometrical openingcomprises a circular or ovular opening.
 71. The stent-valve deliverysystem of claim 59, wherein the at least one attachment element of thestent-valve comprises a wire, hook, or strap configured for removableattachment to a complimentary structure of the stent holder.
 72. Thestent-valve delivery system of claim 59, wherein the at least oneattachment element of the stent-valve comprises at least two attachmentelements configured for removable attachment to corresponding number ofcomplimentary structures of the stent holder.
 73. The stent-valvedelivery system of claim 59, wherein the at least one attachment elementof the stent-valve comprises at least three attachment elementsconfigured for removable attachment to corresponding number ofcomplimentary structures of the stent holder.
 74. The stent-valvedelivery system of claim 59, wherein the stent-valve comprises a latticestructure comprising: at least one commissural post; and the at leastone attachment element.
 75. The stent-valve delivery system of claim 74,wherein the lattice structure of the stent-valve further comprises atleast one supporting element for connecting the at least one commissuralpost to the at least one attachment element.
 76. A method for deliveringa cardiac stent-valve to an implantation site comprising: removablyattaching the stent-valve to a delivery device; delivering thestent-valve to the implantation site in a collapsed configuration;partially proximally expanding the stent-valve while maintaining thestent-valve attached to the delivery device; and making a determinationwith respect to the stent-valve when the stent-valve is in thepartially-expanded configuration.
 77. The method of claim 76, whereinthe making a determination comprises determining whether the stent-valveis positioned correctly at the implantation site.
 78. The method ofclaim 77, further comprising returning the stent-valve to the collapsedconfiguration and repositioning the stent-valve when the stent-valve isnot positioned correctly at the implantation site.
 79. The method ofclaim 76, wherein the making a determination comprises determiningwhether a valve component of the stent-valve is functioning properly.80. The method of claim 79, wherein determining whether the valvecomponent is functioning properly comprises testing whether the valvecomponent will permit sufficient blood-flow.
 81. The method of claim 79,further comprising returning the stent-valve to the collapsedconfiguration and removing the stent-valve from a patient's body whenthe stent-valve is not functioning properly.
 82. The method of claim 76,further comprising causing the stent-valve to fully expand by causingthe stent-valve to detach from the delivery device, when the making adetermination yields a positive response.